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  1. Life Science Angels Innovation and Entrepreneurship in Life Science Investing UCSF QB3 December 1, 2011 Allan May amay@emvllp.com

  2. Summary of Presentation Might Be A Good Time To Pop A Valium You Probably Don’t Have a Science or Engineering Problem You Have a Business Model Problem 2 + 2 = 10X?

  3. The Venture Capital Model 2010-11

  4. The Aftermath of the 2008 Financial Collapse:LPs “Resize” Venture Capital Calpers Pulls Back Its Venture Capital Commitments (11/23/2011) The California Public Employees' Retirement System over the next several years aims to cut its commitment to venture capital from 7% of its $49.4 billion private equity program to 1%. • U.S. venture capital is an asset class funded by LPs • LPs invest by strict percentage allocations in defined asset classes based on comparable returns • Two events coincided: • The public market collapse and subsequent decline in public market values forced LPs to rebalance their portfolios and reduce exposure to the venture capital asset class • LPS finally noticed that 50-75% of all VCs were failing to exceed returns available in public markets • So LPs BOTH reduced the amount and the percentage invested in the “venture” class

  5. Healthcare Funding Drops Amid Regulatory, Financial Uncertainty • VentureWireLifeScience21 October 2011 Through Sept. 30 investment fell by nearly 8% as firms pulled back amid uncertainty about the regulatory climate and their own ability to raise new funds. The drop-off is evident in biotechnology, which normally claims the most health-care dollars. Venture investors put $2.61 billion into 218 biotech financings through the first three quarters, a 7.5% drop from the $2.82 billion spread across 234 rounds during that same span in 2010, the data show. In biotech, investment in early rounds is still strong even though the total amount deployed is declining. Through three quarters there were 88 seed- and first-round biotech deals done, up from 68 during that span in 2010, according to VentureSource.

  6. U. S . VENTURE C API T AL FUNDRAISIN G Fundraising by Y ear 5 - year Average Return Average IRR $ billions 60% $120 50% $100 40% $80 30% $60 $15 billion raised in 2009, compares to average o f 20% $ 1 6 billion from 1 994 - 1 998 $40 10% $20 0% - 10% $0 ’90 ’91 ’92 ’93 ’94 ’95 ’96 ’97 ’98 ’99 ’00 ’01 ’02 ’03 ’04 ’05 ’06 ’07 ’08 ’09 Source: Thomson Reuters 5 - year Average Retu r n is average of the vintage year retu r ns (pooled IRR) as of September 30, 2009 for the trailing five vintage years. 4 VC Fundraising Has Fallen to 1994-98 Levels

  7. Slow VC Fund-Raising Portends Hard Winter For Start-Ups VentureWireLifeScience ,October 10, 12011 This looks to be the fourth year in a row where venture capital investment will surpass fund-raising--and that has some people worried that start-ups are facing a hard winter."That is exactly the trend you would expect if you saw the venture capital industry shrinking, which is exactly what it is doing," said Paul Maeder, a general partner at Highland Capital Partners and chairman of the National Venture Capital Association. "We're in a shakeout. I don't know whether it's the beginning, the middle or the end."Last year, venture firms raised $14.6 billion while venture investments in U.S.-based companies totaled $27.6 billion, according to Dow Jones VentureSource, which tracks venture deals. Investment has exceeded fund-raising since 2008 and the total gap through June 30 was $29.4 billion.

  8. Venture CapitalIs Declining • The amount of capital under management has fallen from $32B to ~$14B • The number of venture firms in the US has fallen from >1,100 to <450 • Public IPOs and M&A activity continue near historical lows • A greater number of existing portfolio companies exist than ever before • Result: the VCs reaction has been to: • protect portfolio companies with inside rounds • invest at later stages rather than invest in first rounds

  9. VC Investment in Biotech & Medtech Is In Even Worse Shape In Billions • Source: PricewaterhouseCoopers/National Venture Capital Association MoneyTree™ Report, Data: Thomson Reuters

  10. Venture Capital in Healthcare In A Crisis • The number of VC firms investing in early stage Medtech and Biotech is down to ~30 – 50 • A substantial portion will be unable to raise another fund • Since 2008, the amount of annual investment in Medtech is down $1-2 B/yr from what would be needed to just sustain existing investments • Probably < 15 funds capable/willing to fund PMAs • Probably < 15 funds willing to fund Diagnostics • Funds willing to invest in Medtech increasingly seek 510ks with less capital requirements and faster exits

  11. First Time Fundings in Healthcare Have Declined Dramatically • Source: PricewaterhouseCoopers/National Venture Capital Association MoneyTree™ Report, Data: Thomson Reuters

  12. In just the last 3 months… • Scale VP Stops Making New Medical Investments Amid Regulatory Concerns • In another setback for the health-care venture industry, Scale Venture Partners said it has stopped making new medical investments because rising regulatory hurdles are making it too difficult to deliver timely returns in the field. The firm typically devoted a quarter to a third of its funds to health care, but it says returns are taking too long to arrive. • Health Care Teams Leave Morgenthaler, ATV To Form New Firm • Both firms invest across various sectors, and both have teams devoted to life sciences and technology. • Prospect Venture Partners Releases LPs From Fourth Fund • Prospect set out to raise $250 million last year but decided to concentrate on its existing portfolio and elected not to deploy the $150 million committed to that fund. • Frazier Healthcare Ventures Shifts From Early-Stage As LPs Fear Risk • The firm said that less than 20% of any new fund would be likely to go to early-stage companies. The shift in strategy and LPs' general wariness of medical technology is attributed to various stumbling blocks in the sector--including a purportedly risk-averse culture at the FDA. • Versant To See Departure Of Four Managing Directors • The four, who make up one-third of the firm's investment team, will not be involved when it sets out to raise a new fund, possibly next year.

  13. PMA = InnovationIND = Innovation How many Original PMAs are predicted to be financed by VCs in 2011 throughout the United States? ~ 10

  14. So Why Is This Happening? In Medtech/Biotech Cost to Exit $15M-30M – 510k $30M-80M - PMA Time to Exit 4 -7 years Size of Exit >80% =/< $125M And What Is Happening Concurrently In Web 2.0 and Digital Media? Costs AND time to exit Size of exit

  15. P1 Trial Fails P2 Trial Fails P3 Trial Fails A Subtle Reminder Or: Why No One Has Made Money in Biotech in the last Decade Probabilities of Success by Phase PreclinicalFails 25% Preclinical(post-DC) 30% PreclinicalSuccessful 75% 100% 70% P1 Trial Successful 70% 25% 75% P2 Trial Successful BLA Refused 15% 53% 30% P3 Trial Successful 75% 16% NDA Successful 85% 12% 10% PreclinicalExpenses Phase 1 Trial Cost Phase 2Trial Cost Phase 3 Trial Cost NDA Filing Cost Probability of Realizing: PreclinicalMilestones Phase 1Milestones Phase 2Milestones Phase 3 Milestones Commercial Revenue (1) The percentages shown reflect the historic average based on estimates from a number of sources: Nature reviews, Bionest Partners, Exane BNP Paribas, DiMasi (Journal of Clinical Oncology, Volume 25), Datamonitor and CMR

  16. What Is All The Capital and Time Spent On? Life Science Angels THE FDA REGULATORY APPROVAL PROCESS AND CLINICAL TRIAL • And COMING SOON: • Reimbursement Studies • Outcomes Trials

  17. Is the FDA Beyond Hope?

  18. US COMPANIES EXPERIENCE WITH 510K REVIEW US COMPANIES EXPERIENCE IN EUROPE ( CE) 10 MONTHS 7 MONTHS From first filing to clearance From first communication to clearance 31 MONTHS From first communication to clearance 510k and CE Mark Regulatory Clearance Timeline FDA SELF-REPORTED 510(K) REVIEW TIME 3 MONTHS “average total elapsed time from receipt to final decision” FDA Impact on U.S. Medical Technology Innovation Nov 2010

  19. US COMPANIES EXPERIENCE WITH PMA REVIEW US COMPANIES EXPERIENCE IN EUROPE ( CE) 11 MONTHS 54 MONTHS From first communication to approval (or to present)filing to clearance From first communication to certificate 3 PMA and CE Mark Regulatory Clearance Timeline FDA SELF-REPORTED PMA REVIEW TIME 3 MONTHS “average total elapsed time from filing for all original PMAs to final decision” • FDA Impact on U.S. Medical Technology Innovation Nov 2010

  20. 400 0 60 350 0 50 510(k)s 300 0 40 250 0 200 0 30 PMAs 150 0 20 100 0 10 5 00 0 0 199 9 200 0 200 1 200 2 200 3 200 4 200 5 200 6 200 7 200 8 2009 17 SOURCE: Calculated from FDA PMA approval and 510(k) clearance data. 510k and PMA approvals 1999-2009 10!!

  21. Medicare National Coverage Trends Analysis of Medicare coverage decisions (1999-2008) shows increased coverage restrictions and higher evidence demands Source: Analysis of Tufts Medicare National Coverage Determinations Database (N=132)

  22. Then, Pile On Top • Reimbursement hurdles • Coverage Pitfalls • Coding Pitfalls • Payment Pitfalls • And the 800 pound gorilla: • PCORI

  23. The New Evidence Based Approach: PCORI Comparative Effectiveness Research • Patient and Community Engagement Research • Provider Incentives and Delivery System Transformation • Biomedical And Clinical Innovator Engagement Evidence-based policy Research on CER Implementation Evidence-based, Affordable Health care Patient Centered Outcomes Research Institute

  24. So Is Anyone Financing The Early Stage?

  25. Venture Capital ~$ .3 billion State Funds ~$ .5 billion Angel Investors ~$20 billion Angels: 90% of outside equity for start-ups? Friends & Family ~$60 billion Angels Are the Real Source of Seed Funding Sources: MoneyTree, NASVF, multiple studies on informal capital

  26. Growth in Number of American Angel Groups Life Science Angels Sources: Center for Venture Research (pre 03 data) and Kauffman Foundation/ACEF (04-09 data)

  27. Angel Capital Mirrors VC Capital in Size Life Science Angels Mostly later stage 3,808 deals $28.3B Early Stage Late $19.2B 55,480 deals Mostly early stage 440 Seed 2008 Angel Investment source: UNH CVR 2008 VC Investment source: NVCA/PWC/Thomson Reuters

  28. Angel Group Investments – 2008-2009 Life Science Angels Source: 2008 ACEF, SVB Angel Group Data Surveys

  29. Life Science Angels Syndication Is Beginning to Increase Investment • Median Length of Time to Close: 90 Days • Median Amount New Funding: $200,000 • Percent Closed as Syndicated Deals 65% Source: 2008 ACEF, SVB Angel Group Data Surveys

  30. Angels Have Different Views of Enhancing Value Than VCs • The financial interest of angels and founders and entrepreneurs are more aligned than with VCs • The financial system is rigged to favor the last money in • Faster exits on less capital are good for founders, entrepreneurs and angels BUT NOT GOOD FOR VCs • Check out www.ownyourventure.com • Angels favor a much wider variety of value building exits than VCs • Finance “products” versus companies • Finance companies with smaller market potential • Sell on proof of principal rather than go to market • Finance license models with dividends/share buybacks

  31. Your Best Financing Pathway Leads Through Angels • You need to network with angels in your geographic area and/or specific field • Learn what they think derisks your company • Use their operational knowledge to solve operational issues • Use their networks to pursue follow on funding • You should spend the same amount of time and effort planning your business and financing model as on your science and engineering • Use www.angelcapitalassociation.org and www.angelresourceinstitute.org to locate angels, BUT network your way in!

  32. But Back to the Premise:What Is The Future Of Innovation? • The System Will Not/Cannot Finance Technologies to Market As In The Past • The money to do that is not there • New Business Models Need Created That Result In • Better Patient Outcomes, • On Less Capital, AND • Which Lower The Costs of Providing Quality Healthcare • Don’t try to bring innovative technologies/discoveries to market using the same amount of capital historically required

  33. There Are Two Likely Scenarios

  34. One Possible Scenario Offshoring the US Medtech and Biotech Industries

  35. Medical TourismGrowing >35%/year The most advanced cancer therapies, the newest minimally invasive surgeries, and the latest implants are all available offshore years before they are available in the U.S. More than 400 hospitals in 39 countries currently have accreditation from Joint Commission International, the international arm of the body that accredits U.S. hospitals A small but growing number of insurance companies have pilot programs to cover procedures abroad In a 2009 Gallup poll, 29 percent of Americans said they would travel abroad to treat a major medical problem Americans can save an average of 50 percent to 80 percent on certain medical procedures if they travel abroad

  36. Five Pillars of Innovation Have Sustained U.S. Medtech Innovation Christopher Wasden, PricewaterhouseCoopers LLP Powerful market and financial incentives resulted in high per capita expenditures and favorable reimbursement Government/NIH support >$25B/yearly FDA was global leader in setting regulatory standards Patients were uninvolved in cost considerations and so price insensitive The venture and angel investment communities were well funded and supportive

  37. The PwC Medical Technology Innovation Scorecard shows that 3 trends are evident: Christopher Wasden, PricewaterhouseCoopers LLP • The innovation ecosystem for medical device technology is moving offshore. • Increasingly, medical technology innovators are going outside the United States to seek clinical data, new-product registration, and first revenue. • U.S. consumers are not always the first to benefit from advances in medical technology and could eventually be last in line. • Innovators already are going first to market in Europe and, by 2020, likely will move into emerging countries next before entering the United States. • The nature of innovation is changing as developing nations become the leading markets for smaller, faster, more affordable devices that enable delivery of care anywhere and help bend the healthcare cost curve downward. • The difficulty of doing business in emerging countries and concerns over intellectual property protection could make these markets less attractive to multinational companies, despite their size, and could hinder these nations’ innovation leadership. • View the full report at www.pwc.com/InnovationScorecard.

  38. Another Possible ScenarioReal Innovation Dr. Thomas J. Fogarty “It Takes More Guts Than Brains To Innovate”

  39. New Value Propositions • Will the implementation of the idea: • Reducecostforthepatientorhealthcareprovider? • Immediately – not over the life of the therapy/condition • Increaseconvenienceforthepatientandtheclinician • ordoctor? • Increasetheconfidenceofthedoctor,clinician,andpatientthe • accuracy,efficacy,ordurabilityofaproductorservice? • Increasecompensationfortheprovider,doctor,or clinician? • Reimbursement based medicine vs Evidence based medicine • There will be a shift from expensive devices with premium features that produce superior clinical results.. to ….generic devices with comparable clinical results and much lower price points

  40. New Titles For Your Presentations • Instead of titles that read like abstracts in professional journals: • “Awesome Translational Breakthrough Combines Nano, Bio and Information Technology to Produce Molecular Level Blah BlahBlah” • Think about: • “We can obtain proof of efficacy in humans on $<1M”, or • “We can get to cash positive operations on ~$3M”, or • “We can replace a $10,000 procedure with a $1,000 procedure and get equal to better patient outcomes”

  41. New Business Models Needed!!!!!

  42. The Way Forward:Business Model Innovations • Ardian vs. CVRx – both devices targeted at a chronic drug condition: refractory hypertension • CVRx – implantable – still in US clinicals; raised >$200M • Ardian - catheter based procedure; European clinicals only; raised $60M; sold for $800M up front + $800M earnout • Acclarent – catheter procedure for sinusitis; got 5 products on market for $5M; raised >$100M; sold to Ethicon for $800M • SmartCells – “Smart” insulin delivery; raised <$10 solely from angels; sold to Merck for $500M

  43. New Business Models in Drug Development • CMEA Advances Virtual Drug Development Effort Velocity Pharma • CMEA has been developing Velocity Pharma over the past several months with a goal of improving biotechnology-investment returns by reducing fixed costs. • Velocity Pharma seeks to acquire individual drugs and treat each one as an individual company • Investing in drug candidates, not in biotech companies • Dream team of drug development experts assembled • Generate returns by developing a portfolio of drugs as discrete entities • Capital Efficient: $5-15 million per drug candidate • Time Efficient: 2.5 years from acquisition to exit on average • High Return: $50-500 million per success

  44. Business Model Innovations Nanostim, Inc (procedure). Sea Medical Systems (safety) BiomimedicaInc (cost; younger patients)

  45. Stuff To Check Out • For Behavioral Change Modeling • BJ Fogg, PhD, Stanford Behavior Design Lab; “Fogg Behavior Index” • To read: • Generally: BioSpaceGenepool; InVivo; Start-Up; Medtech Insights • PWC Medical Technology Innovation Scorecard, Jan 2011 • FDA Impact on Medical Innovation, Nov 2010, Meer and Makower • Medical Device Investing: 2010 and Beyond, Start-Up, Vol 15 No, 10, Dec 2010 • Trends in Life Science Investments and Exits, Oct 2010, SVB Analytics

  46. Need for A Business Co-Founder, Champion, or Mentor • Don’t try flying a 777 first time out;partner with a pilot and fly co-pilot • Network to find someone who has commercialized a comparable technology or discovery • What will they do? • Determine Financeabilityof Business • Plan/Strategy/Replan • Recruit Key Management if necessary • Make Introductions to Angels, where appropriate • Make Introductions to Venture Capitalists, when appropriate • Drive the Funding Process Actively • Prepare for the Follow-on Round

  47. Life Science Angels Innovation and Entrepreneurship In Life Science Investing Allan May amay@emvllp.com